Label: ROTOSXIKA VARICOCE VEINS PLASTER- aesculus chinensis, arnica patch

  • NDC Code(s): 83702-016-11, 83702-016-12
  • Packager: Puning Xinhua Trade Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 24, 2023

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  • ACTIVE INGREDIENT

    Active ingredient: Aesculus chinensis 4g/100g, Arnica 3g/100g

  • PURPOSE

    Purpose: Venous repair

  • INDICATIONS & USAGE

    Use to: Temporarily alleviate discomfort related to varicose veins: lower limb spasms, limb soreness, venous dilation, venous congestion, leg fatigue.

  • DOSAGE & ADMINISTRATION

    Directions: After cleaning and drying the affected area, open the packaging and remove the backing paper. Apply 1-2 patches at a time for 8-12 hours.

  • WARNINGS

    Precautions:
    1.This product is an external product, do not take it internally;
    2.This product is a health care product and does not replace drugs and medical devices fortreatment;
    3.Pregnant women, infants, breastfeeding, and those allergic to this product are prohibited;
    4.Do not use skin allergies, skin damage, skin diseases and other symptoms;
    5.If the skin appears red, itchy and other abnormal conditions during use, please suspend use.

  • QUESTIONS

    Questions or comments? +8617846992567

  • INACTIVE INGREDIENT

    Inactive Ingredients: Citric acid, potassium, softened water

  • STATEMENT OF IDENTITY

    Other information:Sealed packaging, please keep in a cool and dark place.

    Produced by:
    Nanyang Jingzhilan Biotechnology Co., Ltd
    No.6,Road 2,Longsheng IndustrialPark,Wangcun Township, Wolong District,Nanyang City
    OEM Company:Puning Xinhua Trade Co.,Ltd

    Made in China

  • KEEP OUT OF REACH OF CHILDREN

    Same as WARNINGS SECTION

  • PRINCIPAL DISPLAY PANEL

    Rotosxika Varicoce Veins Plaster-83702-016-12Label

  • INGREDIENTS AND APPEARANCE
    ROTOSXIKA VARICOCE VEINS PLASTER 
    aesculus chinensis, arnica patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83702-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AESCULUS CHINENSIS WHOLE (UNII: PGU072XJ6U) (AESCULUS CHINENSIS WHOLE - UNII:PGU072XJ6U) AESCULUS CHINENSIS WHOLE4 g  in 100 g
    ARNICA CORDIFOLIA WHOLE (UNII: 82CNE9JKJI) (ARNICA CORDIFOLIA WHOLE - UNII:82CNE9JKJI) ARNICA CORDIFOLIA WHOLE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83702-016-126 in 1 BAG06/01/2023
    1NDC:83702-016-112.1 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2023
    Labeler - Puning Xinhua Trade Co., Ltd. (632673277)
    Registrant - Nanyang Jingzhilan Biotechnology Co., Ltd. (724044399)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanyang Jingzhilan Biotechnology Co., Ltd.724044399manufacture(83702-016) , label(83702-016)
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